Suturing device

Abstract

A suturing device is provided having at least one weft strand interwoven with a plurality of warp strands to define a body region. The body region has a substantially open mesh configuration, and at least a first elongated end region extends axially from the body region and is integral with the body region, the at least first elongated end region having a substantially closed mesh configuration. The width of the end region is substantially less than the width of the body region.

Description

Technical Field

[0001] This invention relates to a medical device that can be a suturing device for orthopedic repair, such as reattaching muscles or ligaments to tissue from which they have detached, anchoring grafts and repair devices to underlying tissue, or reconstructing damaged or torn tissue. Background Technology

[0002] Traditional surgical techniques require the use of sutures to join soft tissues such as tendons or ligaments or hard tissues such as bone. Sutures are typically constructed with a relatively small diameter, resulting in a small contact area and high contact force, which can cause the suture to cut into adjacent tissues. Summary of the Invention

[0003] The problem to be solved is to provide reinforced sutures with a flatter and wider profile, and to provide improved usability for a range of surgical applications, while allowing for use with existing instruments, improved contact pressure during surgical repair, and the ability to integrate with adjacent tissues.

[0004] The solution to the problem is described in the independent claims. The dependent claims involve further improvements.

[0005] In a first embodiment, a suturing device is provided, comprising at least one weft strand interlaced with a plurality of warp strands to define a body region and at least a first elongated end region. The body region has a substantially open mesh configuration. The first elongated end region extends axially from the body region and forms a portion of the body region, having a substantially closed mesh configuration and a width significantly smaller than the width of the body portion. The suturing device may include a body region located between an adjacent first end region and an optional second end region. The configuration of the body region provides resistance to tissue puncture, and the configuration of the adjacent end regions allows manipulation of the device during surgical procedures.

[0006] Typically, open mesh structures have larger pore sizes than closed mesh structures. The pore size can be defined by the maximum opening between adjacent weft and warp plies. The average pore size is defined as the average of multiple pore sizes of the same pore type. Open mesh structures are characterized by an average pore size, or substantially each pore size, of at least 100 μm, which allows for cellular nutrition while supporting cell migration and proliferation leading to tissue repair. Target pore sizes can be 0.3 mm or 0.5 mm. Pore sizes can be less than 1 mm or 2 mm.

[0007] The closed mesh structure is characterized by an average pore size or essentially each pore size of less than 100 μm, which allows textile fabrics to be packaged into compressed sizes to support their use with existing surgical instruments.

[0008] The main body region and at least one end region may comprise a textile fabric. The textile fabric is intended to encompass a variety of constructions, both interwoven and non-interwoven, whether made by weaving, spinning, knitting, crocheting, braiding, twisting, plying, embroidery, bonding, lamination, nonwovens, or other processes and combinations thereof. The textile construction may be made of ply yarn. The term "ply yarn" is intended to include fibers, monofilaments, multifilament yarns that may be twisted or untwisted, textile constructions such as woven fabrics, or combinations thereof. Ply yarns may have a uniform or varied shape or size. Ply yarns may consist of a uniform material or a combination of various materials. Discrete ply yarns may comprise the same material or different materials. Variations between ply yarns in construction, shape, size, material, coating, or mechanical properties may be geometrically arranged equally or irregularly spaced.

[0009] The apparatus may include multiple interlaced ply yarns, which include multiple warp yarns that may be aligned substantially parallel to the longitudinal axis. It may also include multiple weft yarns that may be aligned substantially transversely to the longitudinal axis. The weft yarns may be provided by individual weft ply yarns extending through the warp yarns. The weft ply yarns may extend back and forth through the apparatus substantially perpendicular to the longitudinal axis of the apparatus and partially along the edge portion of the apparatus substantially parallel to the longitudinal axis of the apparatus. The weft ply yarns may be thicker than the warp ply yarns. The weft yarns may be substantially hollow. The warp yarns may be arranged in adjacent pairs and may interlace with the weft ply yarns to form a leno weave structure (also known as a web structure or cross structure). The ply yarns may include ply fibers. The leno weave may include at least two warp ply yarns twisted in a series of figure-eight patterns around at least one weft ply yarn, wherein the first warp ply yarn passes below the weft ply yarn and above the second warp ply yarn, and the second warp ply yarn passes above the weft ply yarn.

[0010] In one embodiment, the device includes a second elongated end region that extends axially from the body region in a direction opposite to that of the first end region and forms a part of the body region.

[0011] In addition, the device may include a tapered transition region defined between the main body region and / or the end region and forming a part of the main body region and / or the end region.

[0012] In the implementation plan, multiple warp strands include multiple groups of at least two warp strands.

[0013] In the implementation scheme, multiple sets of warp yarns may include multiple sets of adjacent pairs of warp yarns.

[0014] In the implementation scheme, the first warp yarn in the plurality of warp yarns is substantially planar, and the second warp yarn in the plurality of warp yarns is interwoven with at least one weft yarn.

[0015] In one implementation, a set of warp yarns includes a greater number of first warp yarns than the second set of warp yarns.

[0016] In the implementation scheme, the thickness of the first warp yarn is greater than the thickness of the second warp yarn.

[0017] In the implementation scheme, the multiple sets of warp strands in the main area are substantially parallel and spaced apart to define the mesh structure of the openings.

[0018] In the implementation scheme, at least one weft strand extending through at least a portion of the main body region and / or at least a portion of at least one end region comprises multiple weft strands.

[0019] In the implementation scheme, at least one end portion of the main body region includes multiple weft yarns, while the central portion of the main body region includes a single weft yarn.

[0020] In the implementation plan, the two end portions of the main area include multiple weft yarns.

[0021] In the implementation scheme, at least one of the weft yarns in at least one end portion of the main body region is relatively rigid, while the weft yarns in the central portion of the main body region are relatively flexible.

[0022] In the implementation scheme, the relatively rigid weft yarn includes a braided cord, and the relatively flexible weft yarn includes at least one filament.

[0023] In the implementation plan, the first weft yarn in the multiple weft yarn strands is thicker than the second weft yarn in the multiple weft yarn strands.

[0024] In the implementation plan, at least one weft yarn extends substantially longitudinally from a portion of the main body area.

[0025] In the implementation scheme, at least one weft yarn extends substantially along at least one edge of the central portion of the main body area.

[0026] In the implementation scheme, at least one weft strand extends substantially along the relative edge of the central portion of the main body area.

[0027] In the implementation scheme, each weft yarn extends through a separate hole in the warp yarn.

[0028] In the implementation, at least one weft strand in at least one end region includes at least one corded structure.

[0029] In the implementation, at least one end portion of at least one roped structure is substantially hollow.

[0030] In one embodiment, the free end of the warp strand in at least one end region is located within at least one corded structure via one or more splices to define at least one corded end region.

[0031] In the implementation plan, at least one weft strand is provided by a roped structure.

[0032] In the implementation plan, at least one warp strand is provided by a roped structure.

[0033] In one embodiment, a first portion of the free end of the warp strand in at least one end region is located within a first corded structure via one or more splices to define a first corded end region, while a second portion of the free end of the warp strand in at least one end region is located within a second corded structure via one or more splices to define a second corded end region.

[0034] In one embodiment, the first corded end region and the second corded end region are connected to form at least one annular end region.

[0035] In one embodiment, the length of at least one annular end region can be adjusted by allowing at least a first corded end region to pass through a second corded end region.

[0036] In one embodiment, the length of at least one annular end region can be adjusted by allowing at least one of the first corded end region and the second corded end region to pass through it.

[0037] In one implementation, one or more fixed buttons are attached to at least one annular end region.

[0038] In the implementation plan, the main area is substantially planar or tubular.

[0039] According to another embodiment, a method for manufacturing a suturing device is provided. The method includes the following steps:

[0040] At least one weft yarn is interlaced with multiple warp yarns to define a substantially open mesh structure; and

[0041] Tension is applied to at least one weft strand to press the warp strands together and define a body region and at least a first elongated end region, the body region having a substantially open mesh structure, the at least first elongated end region extending axially from the body region and forming a part with the body region, the at least first elongated end region having a substantially closed mesh structure and a width significantly smaller than the width of the body portion.

[0042] In an implementation, the method includes providing a tapered transition region between the main region and / or the end region, the tapered transition region forming a part of the main region and / or the end region.

[0043] In one implementation, the method includes providing multiple sets of at least two warp strands, wherein a first warp strand in one set of warp strands is substantially planar, and a second warp strand in another set of warp strands is interwoven with at least one weft strand.

[0044] In the implementation scheme, the thickness of the first warp yarn is greater than the thickness of the second warp yarn.

[0045] In the implementation, interlacing includes extending a plurality of weft strands through at least a portion of the body region and / or at least a portion of at least one end region.

[0046] In one embodiment, the method includes positioning the free end of a warp strand in at least one end region within a corded and hollow structure of at least one weft strand using one or more twist joints to define at least one corded end region.

[0047] In one embodiment, the method includes positioning the free end of a warp strand in at least one end region within a corded and hollow configuration of at least one warp strand using one or more twist joints to define at least one corded end region.

[0048] In one implementation, the method includes cutting at least one end region near the warp strands that are being pressed together.

[0049] In an implementation, the method includes joining the free ends of warp strands and / or at least one weft strand together. Attached Figure Description

[0050] In the following description, the invention will be illustrated by way of example embodiments with reference to the accompanying drawings, without limiting the general inventive concept.

[0051] Figure 1 The sutures are shown;

[0052] Figure 2a The construction of the stitching device during the first manufacturing stage is shown;

[0053] Figure 2b The construction of the stitching device during another manufacturing stage is shown;

[0054] Figure 3 Another suture is shown;

[0055] Figure 4 The structure of the main region of the first suture is shown;

[0056] Figure 5 The structure of the main region of the second suture is shown;

[0057] Figure 6 The structure of the main region of the third suture is shown;

[0058] Figure 7 The structure of the main region of the fourth suture is shown;

[0059] Figure 8 The structure of the main region of the fifth suture is shown;

[0060] Figure 9 The structure of the main region of the sixth suture is shown;

[0061] Figure 10a The construction of the seventh suture during the first manufacturing stage is shown;

[0062] Figure 10b The construction of the seventh suture during another manufacturing stage is shown;

[0063] Figure 10c The construction of the seventh suture during another manufacturing stage is shown;

[0064] Figure 11a The construction of the eighth suture is shown;

[0065] Figure 11b The construction of the ninth suture is shown;

[0066] Figure 12a The construction of the tenth suture is shown;

[0067] Figure 12b The construction of the eleventh suture is shown;

[0068] Figure 12c The construction of the twelfth suture is shown;

[0069] Figure 12d The construction of the thirteenth suture is shown;

[0070] Figures 13a to 13c A method for manufacturing sutures is shown;

[0071] Figures 14a to 14c The structure of the main area of ​​another suture is shown;

[0072] Figures 15a to 15b Another embodiment with improved warp cords is shown.

[0073] Figures 16a to 16b Another implementation scheme is shown.

[0074] Figure 17a and Figure 17b This schematically illustrates how the aperture can be defined. Detailed Implementation

[0075] like Figure 1 As shown, a surgical suture device 100 according to an embodiment includes a continuous length of suture material. The suture material has one or more defined regions. The device includes a body region 102 located between adjacent first end regions 104 and optionally a second end region 106. The configuration of the body region provides resistance to tissue tearing, and the configuration of the adjacent end regions allows manipulation of the device during surgical procedures. The body region may have a substantially flat, circular, or tubular profile. It may be made of sheet material, textile fabric, or a combination of these configurations. Tapered transition regions 108, 110 are provided between the end regions and the body region.

[0076] Suitablely, the main body region 102 and at least one end region 104, 106 comprise a textile fabric. The textile fabric may include a variety of interwoven and non-interwoven constructions, whether made by weaving, spinning, knitting, crocheting, braiding, twisting, plying, embroidery, bonding, laminating, nonwoven, or other processes and combinations thereof. The textile construction may be made of ply yarn. The term "ply yarn" is intended to include fibers, monofilaments, multifilament yarns that may be twisted or untwisted, textile constructions such as woven fabrics, or combinations thereof. Ply yarn may have a uniform or varied shape or size. Ply yarn may consist of a uniform material or a combination of various materials. Discrete ply yarns may be the same material or different materials. Variations between ply yarns in construction, shape, size, material, coating, or mechanical properties may be geometrically arranged equally or irregularly spaced.

[0077] like Figure 2a As shown, the device 200 suitably includes multiple interlaced ply yarns comprising multiple warp ply yarns 250 (aligned substantially parallel to the longitudinal axis) and multiple weft ply yarns 252 (aligned substantially transversely to the longitudinal axis). Suitably, the weft yarns are provided by single weft ply yarns extending through the warp yarns. Suitably, as shown, the weft ply yarns extend back and forth through the device substantially perpendicular to the longitudinal axis of the device and extend partially along the edge portion of the device substantially parallel to the longitudinal axis of the device. Suitably, the weft ply yarns are thicker than the warp ply yarns. Suitably, the weft yarns are substantially hollow. Suitably, the warp yarns are arranged in adjacent pairs and interlaced with the weft ply yarns to form a leno weave structure (also known as a web structure or cross structure). Suitably, the ply yarns comprise ply fibers.

[0078] Figure 2bAn embodiment is shown with loose ply yarns at at least one of the ends. One or both ends may have loose ply yarns comprising loose warp yarns and / or loose weft yarns. At least one weft ply yarn may be substantially parallel to the warp ply yarns, but may not be wrapped around the warp ply yarns and / or twisted together with the warp ply yarns. Figure 2b As shown, the main body region 202 and at least one end region 204 can be formed by pulling the weft strands 252 out of the structure to form a stroke. This stroke can be pulled until the weft strands combine and lock onto the warp strands 250, which pulls the warp strands toward the central longitudinal axis of the device and forms a tapered transition region 208 between the main body region 202 and at least one end region 204. The loose strands at the ends of at least one end region 204 can be suitably coated with wax, silicone, PTFE, adhesive, etc., to bond them together. Desiredly, the first end region and the second end region can be integrated with the main body region to provide a continuous sewing device. The end regions can include a spread-out main body segment, which can also include loose warp yarns (the free ends of the warp strands) and loose weft yarns, wherein the weft yarns reside in the longitudinal direction. The resulting structure can then be modified in various ways to form the end regions. This can include coating / gluing these loose longitudinal warp and weft strands together. Another example could include twisting loose warp strands into loose longitudinal weft yarns, but this second process is only feasible if the weft yarns have a hollow tubular structure. This tubular structure can also be provided by knitting, weaving, or woven fabric.

[0079] like Figure 3 As shown, the surgical suture system 300 according to an embodiment includes a continuous length of suture material. The body region 302 includes a textile construction having multiple warp yarns and one or more weft yarns, suitably a leno weave construction, with the weft yarns preferably comprising a corded construction. The weft cord is provided by interlaced ply yarns of a knitted, braided, or woven construction. Suitably, the weft cord is a braided construction with a circular hollow profile. Preferably, the ply yarns comprise twisted fibers. Preferably, the weft cord changes orientation as it extends along the device from one region to an adjacent region. For example, as shown, a weft rib extends back and forth through the device (substantially perpendicular to the longitudinal axis) and extends a relatively short distance along the edge portion of the device and substantially parallel to the longitudinal axis. The weft cord may include a flat (or tubular) woven construction for a wider body region (as opposed to a flat, densely packed weave), wherein the woven fabric is formed by multiple warp yarns positioned parallel to the long axis of the device, which are wound around one or more weft yarns extending at approximately 90 degrees to the longitudinal axis. Compared to warp yarns, weft yarns have a relatively wide cross-section and are also used as hollow tubes for hollow stitching.

[0080] The tapered transition 308 between the main region 302 and the end region 304 is formed by pulling the weft cord (i.e., applying tension to the weft cord) and pulling it out of the structure in a substantially longitudinal direction to provide a stroke that locks the warp strands and pulls them toward the central axis. The weft cord is substantially parallel to the orientation of the warp strands. Loose strands adjacent to the tapered section are suitably placed within the longitudinally oriented hollow weft cord via a single or series of splices that extend throughout the length of the end regions 304, 306 or terminate at a distance from the end.

[0081] Regions 312 and 314 are the weft cords after being repositioned to the warp direction. Then, the free end of the mesh in main region 302 is pulled into this hollow tubular weft cord. (As shown...) Figure 3 As shown, the mesh material travels a short distance within the weft ribs, specifically between the tapered portion 310 at the end of the body 302 and the starting point of the end region 306, where the tapered portion can be relatively thin. Therefore, the end region 306 is composed of identical weft yarns without any mesh structure within it.

[0082] This arrangement allows the weft cord to lock the warp yarn at the tapered section while providing the tapered section itself. This arrangement also allows for easier splicing, provides a smooth tapered transition from the body region 302 to the end region 306, which allows for easy passage through tissue and provides fine, dense cord ends for easy passage through surgical instruments and formation of a fixation mechanism.

[0083] According to alternative embodiments, the surgical device may include an open mesh structure that allows a relatively wide profile to be formed from a similar amount of material. This provides increased coverage to enhance engagement with adjacent tissues and also promotes inward tissue growth and postoperative repair.

[0084] like Figure 4As shown, the main body region 402 may include a mesh structure with openings of pairs of warp ply 450 having similar or equal intervals to form a leno weave structure. The warp ply 450 are interwoven with the weft ply 452. Leno construction differs from woven construction (although described using the same terms warp and weft). The main difference is that adjacent warp ply 450 (placed longitudinally) are intertwined in the area between consecutive single weft ply 452 (placed laterally), which can form helical pairs or a series of figure-eights, effectively “locking” each weft ply 452 in place. In this helical pair, the first warp ply always passes below the weft ply 452 and above the second warp ply, and the second warp ply always passes above the weft ply 452. In contrast, in woven construction, the warp ply do not intertwine with each other and are similar to a linear orientation, where each warp ply passes below and above consecutive weft ply. However, in order to achieve the strength desired for some applications, a large number of warp plies or relatively large warp plies can be provided per unit fabric width, thereby reducing the aperture and potentially impairing the incorporation of the fabric.

[0085] like Figure 5 As shown, two or more sets of spaced-apart pairs of adjacent warp ply 550 are provided, which allow more ply to be incorporated per fabric width, thereby increasing its strength, while also enabling the increase of aperture and optimization for structure incorporation.

[0086] like Figure 6 As shown, two or more sets of spaced-apart pairs of adjacent warp plies 650 are provided, one pair including “parallel” plies 651. For example, one ply 651 from the warp pair is placed ‘parallel’ (essentially planar) in the fabric, while the other ply 653 of the warp pair interweaves with the weft ply 652, thus combining the parallel warp and weft plies. The parallel warp plies bear most of the applied axial load, and due to their parallel orientation, this construction provides increased elongation when placed under axial load.

[0087] Appropriately, such as Figure 7 As shown, this configuration can incorporate more parallel warp plies 751 than the number of 'bonded' warp plies 753. This configuration may be desirable where it can provide increased fabric stiffness.

[0088] Preferably, the parallel warp ply 751 has a larger diameter than the combined warp ply 753. This allows for the formation of a particularly desirable fabric with relatively high strength (larger number of warp yarns), relatively high stiffness (parallel warp yarns), and optimal pore size for weave incorporation.

[0089] Alternatively, one or more combined warp plies may have a diameter similar to, larger than, or smaller than the other plies. One or more parallel warp plies may have a diameter similar to, larger than, or smaller than the other plies. One or more weft plies may have a diameter similar to, larger than, or smaller than the other plies. One or more warp plies and / or weft plies may be equally spaced or unequally spaced. For example, as... Figure 14a As shown, the transverse portions 1453 of the weft yarn ply 1452 can be substantially parallel and equidistant from another portion. Alternatively, as... Figure 14b As shown, the transverse portions 1453 of the weft yarn ply 1452 can be substantially parallel to the other portion but not equidistant from the other portion. Further alternatively, as... Figure 14c As shown, the transverse portion 1453 of the weft yarn 1452 may not be parallel to the other portion.

[0090] According to an alternative embodiment, the main body region of the device may include an open mesh structure, and at least one end region may have a thinner structure to facilitate passage through tissue and eye openings in surgical instruments. As previously described, the thinner end region may be formed by a series of tapered portions joined and / or spliced ​​together.

[0091] like Figure 8 As shown, the main body region 802 of the device according to an alternative embodiment may include an open mesh structure comprising multiple weft yarns 852, 854 to form a leno weave structure. This provides the capability for different structures along the length of the device.

[0092] like Figure 9 As shown, portions of the main body region 902 may have more or fewer weft yarns than adjacent portions. For example, end portions 903, 905 of the main body region may have multiple weft yarns, while the central portion 901 of the main body region may have fewer weft yarns. This provides a central portion 901 of the main body region with an optimized structure for tissue incorporation and end portions 903, 905 with optimized structures for connection with bone, soft tissue, fixation devices, etc. Alternatively, the central portion 901 has more weft yarns than the adjacent end portions 903, 905.

[0093] According to alternative implementation schemes, such as Figures 10a to 10cAs shown, one or more weft yarns at one or both ends of the main body region 1002 may comprise a braided cord into which warp yarns and additional weft yarns can be twisted to form end region 1004. Other weft yarn plies are formed from filaments together with the warp yarn plies, providing a soft and flexible middle portion 1001 for reinforcing the inward growth of the main body region 1002, while the end portions 1003, 1005 of the main body region 1002 have optimized construction to aid in securing and forming a transition to the end cord.

[0094] According to an alternative embodiment, the weft yarns in the end portions 1103, 1105 of the main body region 1102 are continuous, wherein one or more weft yarns 1152 extend at least partially along the edge of the central portion 1101 of the main body region and are substantially parallel to the longitudinal axis. This arrangement provides the main body region 1102 with a soft and flexible middle portion to enhance inward tissue growth, while the edge portions of the main body region have increased strength provided by the second weft yarn. Figure 11a A device with an end region 1106 is shown. Figure 11b An apparatus having two end regions 1104, 1106 is shown.

[0095] According to the alternative implementation, multiple sets of weft yarns can be used. In the first example, such as... Figure 12a As shown, the first rope end 1260 is twisted together with the remaining weft and warp yarns within the second rope end 1262 to provide a single end region 1204. In the second example, as... Figure 12b As shown, the weft yarn has discrete ends to provide a pair of spaced-apart end portions 1204, 1205 extending from at least one end region of the device. In the third example, as... Figure 12c As shown, the weft yarns are discrete ends, which are then twisted together to form loops 1206. In the fourth example, as... Figure 12d As shown, the weft yarns are discretely ended and then twisted together to form an adjustable-length loop 1207. This arrangement provides a fixation mechanism that allows the device to be attached to the tissue. For example, the adjustable-length loop can be formed by a weft yarn that penetrates the seam wall of the opposite weft yarn.

[0096] Weft yarn 1204 penetrates the opposing weft yarn 1205, enters at point 1208 and resides within the cavity of the opposing weft yarn 1205, exiting at point 1210, thus forming a loop. The length of this loop is adjustable when the free end of rope 1211 is pulled, and the length of the loop is locked when the loop 1207 is under load. Similarly, weft yarn 1205 penetrates the opposing weft yarn 1204 at point 1213, passes within the weft yarn 1204, and exits at point 1215, forming the free end of rope 1217. Alternatively, any weft yarn rope can form discrete adjustable loops by passing through itself. Alternatively, buttons can be attached to one or more loops to aid in securing them.

[0097] According to an alternative embodiment, the device is suitably configured to facilitate the removal of excess material after implantation. Typically, the mesh structure of such openings is unstable when cut to a certain length, with the strands at the ends of the device abrading and unraveling as the fabric structure unwinds. A method is described for cutting the device 1300 to a first length ( Figure 13a By pulling the weft yarn ply 1352 until the weft yarn ply combines and locks to the warp yarn ply 1350, Figure 13b To form the stroke, the device can then be cut into a second length shorter than the first length, while maintaining the connecting strands ( Figure 13c This creates a stabilizing end for the device, which will not further untangle the bond. Appropriately, the spacing between adjacent channels of the weft yarns is set to facilitate this action. As an example, if a length of 16 mm is required to pull the yarn before bonding, and if adjacent weft channels are spaced 2 mm apart, then when the bond can be located in a specific position (e.g., adjacent to a knot), eight weft channels are counted backward from the desired position and a first length cut is made, then the bond is positioned at the desired location. Appropriately, the weft yarn has a larger diameter than the warp yarn, is formed by a woven structure, and has a different color than the warp yarn, making it easily identifiable for this method.

[0098] According to alternative implementations, one or more warp threads can be used. In the first example, such as... Figure 15a As shown, a first warp cord 1502 extends along the edge of the central portion 1501 of the body region and is substantially parallel to the longitudinal axis. A second warp cord 1503 extends along the opposite edge of the central portion 1501 of the body region. Warp cords 1502 and 1503 are paired with warp ply yarns 1506 and 1507 to bond the warp cords to the body region. This arrangement provides a soft and flexible middle portion of the body region 1501 to enhance tissue growth inward, while the edge portions of the body region have increased strength provided by the warp cords. In the second example, as... Figure 15bAs shown, each warp cord 1555 is joined to the body region by one or more weft strands 1552 and adjacent pairs of warp configurations 1550. Preferably, the end portion extending from at least one end region of the device is formed by twisting the warp cord and warp filaments into one or more weft yarns that may include a braided cord. According to an embodiment, the end portion extending from at least one end region of the device is formed by twisting the weft yarn and warp filaments into one or more warp cords. According to an embodiment, the end portion extending from at least one end region of the device is formed by twisting the weft cord, warp cord, and warp filaments.

[0099] exist Figure 16a and Figure 16b Another implementation scheme is shown in the image. And... Figure 8 In one implementation, two weft plies pass through the same twist formed by a pair of warp plies, where each of the two weft plies can be defined by a separate twist. Further weft plies can be defined by the same or different twists. Weft plies can comprise yarns and / or knitted fabrics. Figure 16a The diagram shows an implementation with two similar weft yarns 852 and 853. Figure 16b An implementation scheme with different types of weft yarns 852 and 854 is shown.

[0100] The construction of any region of the device, regarding its width, length, cross-sectional shape, density, aperture, material type, and mechanical properties, can be adapted to its function, whereby the mechanical properties may include one or a combination of the following: strength, stiffness, wettability, flexibility, and absorption rate, and any region may have variations in any or a combination of the aforementioned physical or mechanical properties. Variations in the properties of the warp or weft ply may be substantially equidistant or unequally spaced. One or more warp ply may include a different cross-sectional size than the other warp ply. The warp ply may be equal to, greater than, and / or less than the denier of the weft ply. The body region of the device may have corrugations in its surface to provide increased frictional resistance to aid in knotting. One or more of the warp ply may include a larger cross-sectional area to form one or more ridges. One or more of the weft ply may include a larger cross-sectional area to form one or more ridges. The cross-section of the body region may be planar or tubular.

[0101] The stitching material can be a single material or a blend. Materials used to manufacture textiles can include bioabsorbable or non-bioabsorbable substances from natural or man-made sources, including, for example, silk, cotton, ultra-high molecular weight polyethylene (UHMWPE), polyamide (Nylon), polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), poly(dioxanone) polyetheretherketone (PEEK), polyetherketoneketone (PEKK), graphene, or bioabsorbable materials, whether as a single material or a blend. A combination of ultra-high molecular weight polyethylene (UHMWPE) and polyethylene terephthalate (PET) can be used to provide strength and improved knotting properties, respectively. Pairs of warp strands can be used, where one strand is UHMWPE and the other is PET. Preferably, the UHMWPE has a larger cross-sectional area, effectively a larger denier, and is substantially parallel to transfer the load, while the smaller denier PET strand is used to bond the UHMWPE strand to the weft strand. Colored strands can be incorporated to improve visibility during use. These colored strands are appropriately made from dyed UHMWPE, PET, or nylon fibers. Different areas can be identified using different colors or color patterns.

[0102] The implementation provides a suturing device that offers improved usability for a range of surgical applications while allowing for use with existing surgical instruments. The device is configured to improve pressure distribution on adjacent tissues during and after surgical repair and to reduce / eliminate any undesirable contact forces that could lead to cutting of adjacent tissues. The device is configured to provide improved strength and optimized connection with bone, soft tissue, or fixation devices. The device includes a relatively wide and open mesh body region to form a large coverage area resistant to tissue puncture and to facilitate tissue interaction. A relatively thin end region is adapted to pass through relatively small orifices in standard surgical instruments to facilitate efficient passage through tissue during surgical procedures.

[0103] Figure 17a and Figure 17b This schematically illustrates how the aperture can be defined. Figure 8 The implementation is used as an example in part, but the aperture limitation can be applied to any implementation disclosed herein.

[0104] Preferred limitations such as Figure 17a The diagram shows the diameter of the circle within the gap between adjacent strands. An open aperture has a circle with a diameter of 866, which can be greater than 100 μm. A closed aperture has a circle with a diameter of 868, which can be less than 100 μm. Typically, an open aperture has a larger circle than a closed aperture.

[0105] If the distance between the weft plies is greater than the distance between the warp plies, then the diameter of the circle is primarily determined by the distance between the warp plies. This is in... Figure 17b As shown in the diagram, the distance 858 of the smaller gap between the weft yarns is approximately the same as the distance of the smaller circle 868. Furthermore, the distances of the larger gaps 856 and 857 are approximately the same as the distance of the larger circle 866. Therefore, the distance between adjacent weft yarns can be used as a simplified measurement of the aperture.

Claims

1. A suturing device (100), the suturing device comprising: Main region (102), the main region comprising multiple weft yarns interwoven with multiple warp yarns in a leno weave, wherein at least one of the weft yarns has a thickness greater than that of each of the multiple warp yarns, and At least one first elongated end region (104), the at least one first elongated end region extending axially from the main body region (102) and forming a part of the main body region and having a width smaller than the width of the main body region (102), Multiple weft yarns interlaced with multiple warp yarns to define a main region (102) and at least one first elongated end region (104), the main region having a substantially open mesh structure, the at least one first elongated end region extending axially from the main region (102) and forming a part of the main region, the at least one first elongated end region having a substantially closed mesh structure, wherein the at least one first elongated end region (104) comprises at least one of the multiple weft yarns. The first weft yarn in the plurality of weft yarns is thicker than the second weft yarn in the plurality of weft yarns.

2. The suturing device (100) according to claim 1, Its features are: The average pore size of open mesh structures is greater than 100 μm, while the average pore size of closed mesh structures is less than 100 μm.

3. The suture device (100) according to claim 1 or 2, Its features are: The leno weave includes a first warp ply and a second warp ply twisted in a series of figure-eight patterns around the multiple weft ply yarns, wherein the first warp ply yarns pass below the weft ply yarns and above the second warp ply yarns, and the second warp ply yarns pass above the weft ply yarns.

4. The suture device (100) according to claim 1 or 2, Its features are: At least one of the weft yarns is a stitching thread.

5. The suture device (100) according to claim 1 or 2, Its features are: The second elongated end region (106) extends axially from the main body region (102) and is disposed in the opposite direction to the first elongated end region (104), and forms a part with the main body region (102), and / or At least one first elongated end region (104) does not have corrugations and / or has a constant width.

6. The suturing device (100) according to claim 3, Its features are: The plurality of warp plies comprises multiple groups of at least two warp plies, wherein any group of warp plies comprises adjacent pairs of warp plies, and / or The multiple warp strands in the main area (102) are parallel and spaced apart.

7. The suturing device (100) according to claim 6, Its features are: The first warp ply in a set of warp plies is planar, and the second warp ply in the set of warp plies is interwoven with at least one of the weft plies, and / or Any set of warp plies includes more first warp plies than the second warp plies, and / or The thickness of the first warp yarn is greater than the thickness of the second warp yarn.

8. The suturing device (100) according to claim 1 or 2, Its features are: At least one end portion of the main body region (102) includes multiple weft yarns, while the central portion of the main body region (102) includes a single weft yarn.

9. The suturing device (100) according to claim 8, Its features are: At least one weft yarn in the at least one end portion of the main body region (102) is more rigid than the weft yarn in the center portion of the main body region (102), and The more rigid weft yarn includes a braided cord, and the weft yarn in the central portion of the main body region (102) includes at least one filament.

10. The suturing device (100) according to claim 1 or 2, Its features are: At least one of the weft yarns extends longitudinally from a portion of the main body region (102), and / or At least one of the weft yarns extends along at least one edge of the central portion of the main body region (102), and / or At least one of the weft yarns extends along the opposite edge of the central portion of the main body region (102), and / or At least one of the weft strands in the at least one first elongated end region (104) includes at least one corded structure.

11. The suturing device (100) according to claim 1 or 2, Its features are: At least one weft strand of the at least one first elongated end region (104) includes at least one corded structure, at least one end portion of the at least one corded structure being hollow, and The free end of the warp strand of the at least one first elongated end region (104) is located inside the at least one corded structure via one or more splices to define at least one corded end region.

12. A suturing device (100), the suturing device comprising: Main region (102), the main region comprising multiple weft yarns interwoven with multiple warp yarns in a leno weave, wherein at least one of the weft yarns has a thickness greater than that of each of the multiple warp yarns, and At least one first elongated end region (104), the at least one first elongated end region extending axially from the main body region (102) and forming a part of the main body region and having a width smaller than the width of the main body region (102), The average aperture of the main body region (102) is greater than the average aperture of the at least one first elongated end region (104). The first weft yarn in the plurality of weft yarns is thicker than the second weft yarn in the plurality of weft yarns.

13. The suturing device (100) according to claim 12, Its features are: The average pore size of the main body region (102) is at least 100 μm and / or the average pore size of the at least one first elongated end region (104) is less than 100 μm.

14. The suture device (100) according to claim 12 or 13, Its features are: The leno weave includes a first warp ply and a second warp ply twisted in a series of figure-eight patterns around the multiple weft ply yarns, wherein the first warp ply yarns pass below the weft ply yarns and above the second warp ply yarns, and the second warp ply yarns pass above the weft ply yarns.

15. The suture device (100) according to claim 12 or 13, Its features are: At least one of the weft yarns is a stitching thread.

16. The suture device (100) according to claim 12 or 13, Its features are: The second elongated end region (106) extends axially from the main body region (102) and is disposed in the opposite direction to the first elongated end region (104), and forms a part with the main body region (102), and / or At least one first elongated end region (104) does not have corrugations and / or has a constant width.

17. The suturing device (100) according to claim 14, Its features are: The plurality of warp plies comprises multiple groups of at least two warp plies, wherein any group of warp plies comprises adjacent pairs of warp plies, and / or The multiple warp strands in the main area (102) are parallel and spaced apart.

18. The suturing device (100) according to claim 17, Its features are: The first warp ply in a set of warp plies is planar, and the second warp ply in the set of warp plies is interwoven with at least one of the weft plies, and / or Any set of warp plies includes more first warp plies than the second warp plies, and / or The thickness of the first warp yarn is greater than the thickness of the second warp yarn.

19. The suturing device (100) according to claim 12 or 13, Its features are: At least one end portion of the main body region (102) includes multiple weft yarns, while the central portion of the main body region (102) includes a single weft yarn.

20. The suturing device (100) according to claim 19, Its features are: At least one weft yarn in the at least one end portion of the main body region (102) is more rigid than the weft yarn in the center portion of the main body region (102), and The more rigid weft yarn includes a braided cord, and the weft yarn in the central portion of the main body region (102) includes at least one filament.

21. The suturing device (100) according to claim 12 or 13, Its features are: At least one of the weft yarns extends longitudinally from a portion of the main body region (102), and / or At least one of the weft yarns extends along at least one edge of the central portion of the main body region (102), and / or At least one of the weft yarns extends along the opposite edge of the central portion of the main body region (102), and / or At least one of the weft strands in the at least one first elongated end region (104) includes at least one corded structure.

22. The suturing device (100) according to claim 12 or 13, Its features are: At least one weft strand of the at least one first elongated end region (104) includes at least one corded structure, at least one end portion of the at least one corded structure being hollow, and The free end of the warp strand of the at least one first elongated end region (104) is located inside the at least one corded structure via one or more splices to define at least one corded end region.

23. A suturing device (100), the suturing device comprising: Main region (102), the main region comprising multiple weft yarns interwoven with multiple warp yarns in a leno weave, wherein at least one of the weft yarns has a thickness greater than that of each of the multiple warp yarns. At least one first elongated end region (104), the at least one first elongated end region extending axially from the main body region (102) and forming a part of the main body region and having a width smaller than the width of the main body region (102), and At least one tapered transition region (108) is defined between the main body region (102) and the first elongated end region (104) and forms a part of the main body region and / or the first elongated end region, wherein At least one warp strand and at least one weft strand of the plurality of warp strands are joined to form a first elongated end region (104). The first weft yarn in the plurality of weft yarns is thicker than the second weft yarn in the plurality of weft yarns.

24. The suturing device (100) according to claim 23, Its features are: The leno weave includes a first warp ply and a second warp ply twisted in a series of figure-eight patterns around the multiple weft ply yarns, wherein the first warp ply yarns pass below the weft ply yarns and above the second warp ply yarns, and the second warp ply yarns pass above the weft ply yarns.

25. The suture device (100) according to claim 23 or 24, Its features are: At least one of the said weft yarns is a stitching thread, and / or The at least one tapered transition region (108) includes at least one of the plurality of warp strands twisted into the weft strands.

26. The suture device (100) according to claim 23 or 24, Its features are: The second elongated end region (106) extends axially from the main body region (102) and is disposed in the opposite direction to the first elongated end region (104), and forms a part with the main body region (102), and / or At least one first elongated end region (104) does not have corrugations and / or has a constant width.

27. The suturing device (100) according to claim 24, Its features are: The plurality of warp plies comprises multiple groups of at least two warp plies, wherein any group of warp plies comprises adjacent pairs of warp plies, and / or The multiple warp strands in the main area (102) are parallel and spaced apart.

28. The suturing device (100) according to claim 27, Its features are: The first warp ply in a set of warp plies is planar, and the second warp ply in the set of warp plies is interwoven with at least one of the weft plies, and / or Any set of warp plies includes more first warp plies than the second warp plies, and / or The thickness of the first warp yarn is greater than the thickness of the second warp yarn.

29. The suture device (100) according to claim 23 or 24, Its features are: At least one end portion of the main body region (102) includes multiple weft yarns, while the central portion of the main body region (102) includes a single weft yarn.

30. The suturing device (100) according to claim 29, Its features are: At least one weft yarn in the at least one end portion of the main body region (102) is more rigid than the weft yarn in the center portion of the main body region (102), and The more rigid weft yarn includes a braided cord, and the weft yarn in the central portion of the main body region (102) includes at least one filament.

31. The suture device (100) according to claim 23 or 24, Its features are: At least one of the weft yarns extends longitudinally from a portion of the main body region (102), and / or At least one of the weft yarns extends along at least one edge of the central portion of the main body region (102), and / or At least one of the weft yarns extends along the opposite edge of the central portion of the main body region (102), and / or At least one of the weft strands in the at least one first elongated end region (104) includes at least one corded structure.

32. The suture device (100) according to claim 23 or 24, Its features are: At least one weft strand of the at least one first elongated end region (104) includes at least one corded structure, at least one end portion of the at least one corded structure being hollow, and The free end of the warp strand of the at least one first elongated end region (104) is located inside the at least one corded structure via one or more splices to define at least one corded end region.

33. A method of manufacturing a suturing device, the method comprising: A mesh structure in which multiple weft yarns are interwoven with multiple warp yarns in a leno weave to define an opening, wherein at least one weft yarn has a thickness greater than that of each of the multiple warp yarns. as well as Tension is applied to the plurality of weft yarns to press the warp yarns together and define a main body region (102) and at least one first elongated end region (104), the main body region having an open mesh structure, the at least one first elongated end region extending axially from the main body region (102) and forming a part of the main body region, the at least one first elongated end region having a closed mesh structure and a width smaller than the width of the main body region. The first weft yarn in the plurality of weft yarns is thicker than the second weft yarn in the plurality of weft yarns.

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